Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia

Schizophrenia Clinical Trial

Official title:

Effect of Intranasal Vasopressin on Cooperative Behavior in Schizophrenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04190004
• Other study ID #: IEC/2017
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: November 30, 2018

Study information

• Verified date: December 2019
• Source: National Institute of Mental Health and Neuro Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study investigates the effect of 40IU of intranasal vasopressin on cooperative behavior in patients with schizophrenia

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 30, 2018
• Est. primary completion date: November 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Age 18-45 years

• Diagnosed as Schizophrenia or Schizophreniform disorder as per DSM IV TR

• At least 7 years of formal education

• MOCA score >24

Exclusion Criteria:

• Diagnoses of SIADH, Diabetes Insipidus

• Substance dependence in the past 12 months, excluding nicotine dependence

• Current comorbid axis 1 psychiatric disorder

• Hypersensitivity or previous allergy to Vasopressin

• Serious medical or neurological illness which may interfere with assessment and administration of vasopressin

• Hypertension

• Impaired renal functions based on serum creatinine above 1.5

• Electrolyte imbalance

• Receiving ECT or has received ECT in the past 8 weeks

• Clinical history of mental retardation

• Pregnancy • Lactation

• Risk of harm to self or others

• Any significant nasal pathology which may hinder the intranasal absorption of the drug

• Hearing or visual impairment that significantly affects the comprehension and execution of the study

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Vasopressins
40 International units of vasopressin or placebo will be given intra-nasally. The order of the administration will be counterbalanced
• Placebo
40 International units of vasopressin or placebo will be given intra-nasally. The order of the administration will be counterbalanced

Locations

Country	Name	City	State
India	National Institute of Mental Health and Neurosciecnes	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Mental Health and Neuro Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Performance in Dictator game	Amount of money shared in dictator game	60 minutes
Primary	Performance in stag hunt game	Security level in stag hunt game	60 minutes